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Guidewires for Peripheral Application

by EPflex Feinwerktechnik GmbH United States EUDAMED

Ref 44013527

EMDN U0602

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number1000265993 Date27 Oct 2025IssuedStatusActive expires 8 Nov 2028

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 1000265993 Issued

    Quality management system EU MDR

    Notified body
    Notified body 0297
    Issued
    27 Oct 2025
    Expires
    8 Nov 2028

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Guidewires for Peripheral Application
Model / Reference
44013527
Primary DI / UDI-DI
04255605608960
Basic UDI-DI
42556056gwcIIaFP
EMDN Code
U0602 Urological guidewires, not hydrophilic
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000005425

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • CMR Substance
Other properties (11)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 91a4c303-e774-456c-b247-d34141d2fd45 61 fields · synced 23 Oct 2026